Valsartan, Sacubitril for Breast cancer | Post-anthracycline cardiomyopathy

Inclusion criteria

• {"criterion_text":"-Written informed consent"}
• {"criterion_text":"-Sinus rhythm"}
• {"criterion_text":"-Female gender, aged 18 years and over"}
• {"criterion_text":"-Patients with histologically confirmed breast cancer and complete assessment of tumor phenotype (ER, PR, HER2, Ki67)"}
• {"criterion_text":"-Ability to take oral medication and willingness to adhere to the planned regimen"}
• {"criterion_text":"-Tumor grade IA-IIIC or oligometastatic grade IV"}
• {"criterion_text":"-Radical treatment plan including surgery or post-radical surgical treatment"}
• {"criterion_text":"-Plan of use of systemic treatment (preoperative, postoperative or combined) with anthracyclines and/or anti-HER2 drugs"}
• {"criterion_text":"-ECOG 0-2 general status"}
• {"criterion_text":"-LVEF ≥ 50% as assessed by echocardiography"}

Exclusion criteria

• {"criterion_text":"-Lack of Written informed consent"}
• {"criterion_text":"-Contraindications to ACE-I/ARB or LCZ696 if not listed among criteria"}
• {"criterion_text":"-Active untreated liver disease"}
• {"criterion_text":"-Pregnancy"}
• {"criterion_text":"-Conditions/circumstances that may lead to non-compliance with medical staff recommendations (e.g. active drug/alcohol dependence, poorly controlled mental illness)"}
• {"criterion_text":"-Prior anthracycline-based chemotherapy and/or left-sided radiotherapy (prior to diagnosis of the cancer being the present cause of XML File Identifier: xW+Ea9mm17kcx3fLB1UWMlFS0h4=Page 16/27 therapy)"}
• {"criterion_text":"-Clinically relevant HF (NYHA II-IV)"}
• {"criterion_text":"-MI within the last < 3 months"}
• {"criterion_text":"-Symptomatic hypotension or SBP < 90 mmHg"}
• {"criterion_text":"-Significant valvular disease, symptomatic coronary artery disease (CCS>2), significant AV block, symptomatic sinus node dysfunction"}
• {"criterion_text":"-Expected survival <12 months"}
• {"criterion_text":"-GFR<30 ml/min/1.73 m2 (screening visit)"}
• {"criterion_text":"-K+>5.5mmol/L (screening visit)"}

Primary endpoints

• {"endpoint_text":"-Decrease in left ventricular ejection fraction ≥ 5% assessed on magnetic resonance imaging (MRI) in 24 months from randomisation","definition_or_measurement_approach":"Assessed on magnetic resonance imaging (MRI) within 24 months from randomisation"}

Secondary endpoints

• {"endpoint_text":"-Death from any cause or hospitalization for heart failure","definition_or_measurement_approach":""}
• {"endpoint_text":"-Death from any cause","definition_or_measurement_approach":""}
• {"endpoint_text":"-Death from cardiovascular causes","definition_or_measurement_approach":""}
• {"endpoint_text":"-Hospitalization for other cardiovascular causes","definition_or_measurement_approach":""}
• {"endpoint_text":"-cardiotoxicity","definition_or_measurement_approach":"Defined as Cancer therapy-related cardiac dysfunction (CTRCD) resulting in need to start treatment according to ESC cardio-oncology guidelines; described as LVEF ≥ 5% (MRI) within 24 months from randomization"}
• {"endpoint_text":"-Decrease in left ventricular ejection fraction ≥ 5% (MRI) during 24 months from randomization","definition_or_measurement_approach":"Assessed by MRI during 24 months from randomization"}
• {"endpoint_text":"-Decrease in left ventricular ejection fraction ≥ 5% during 24 months from randomization","definition_or_measurement_approach":""}
• {"endpoint_text":"-Occurrence of diastolic dysfunction (UKG) within 24 months of randomization Diastolic dysfunction assessed on echocardiography","definition_or_measurement_approach":"Diastolic dysfunction assessed by transthoracic echocardiography (UKG) within 24 months"}
• {"endpoint_text":"-Development of pathological pericardial fluid volume or increase in pericardial fluid volume from baseline","definition_or_measurement_approach":""}
• {"endpoint_text":"-Occurrence of cardiac tamponade","definition_or_measurement_approach":""}
• {"endpoint_text":"-Occurrence of pericarditis","definition_or_measurement_approach":""}
• {"endpoint_text":"-Occurrence of myocarditis","definition_or_measurement_approach":""}
• {"endpoint_text":"-Development of ventricular arrhythmias","definition_or_measurement_approach":""}
• {"endpoint_text":"-Development of supraventricular arrhythmias","definition_or_measurement_approach":""}
• {"endpoint_text":"-Presence of conduction disturbances","definition_or_measurement_approach":""}
• {"endpoint_text":"-Changes in corrected QT interval","definition_or_measurement_approach":""}
• {"endpoint_text":"-Changes in BNP, NT pro-BNP, troponin T or troponin I levels","definition_or_measurement_approach":"Biomarker level changes according to cutoffs described in ESC guidance (BNP/NT-proBNP and troponin T/I as per ESC-defined thresholds)"}

Poland

Earliest CTIS Part Ii Submission Date

23-10-2024

Latest Decision Or Authorization Date

26-10-2025

Processing Time Days

368

Number Of Sites

5

Number Of Participants

600

Primary sponsor

Full Name

Slaskie Centrum Chorob Serca W Zabrzu

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Scientia Research Institute Sp. z o.o.","duties_or_roles":"Codes: 1,11,6,7,8,9","organisation_type":"Pharmaceutical company"}